Week in Review, May 20, 2013

The PharmaCertify™ Team

Break out the tutus and tap shoes and fire up your fingers, bows and reeds. It’s recital time! Let the tears of pride and joy flow, moms and dads. As the little ones prepare to showcase their best dance moves, we showcase all the news fit to print from the world of compliance, with this week’s News Week in Review.

Ranbaxy danced into the headlines this week, announcing a $500 million settlement to resolve charges it sold adulterated drugs and made false statements to the FDA. The company pled guilty to three felony counts of violating drug safety law and making false statements. Criminal fines and forfeitures total $150 million and the remaining $350 million will settle civil cases with both the feds and states.

Also playing out of tune was device manufacturer, C.R. Bard. The company signed a non-prosecution agreement with the DOJ and agreed to pay a $48.3 million settlement to resolve False Claims Act charges. Bard was accused of providing grants, free equipment and other kickbacks to physicians and other customers who purchased its prostate cancer radiation treatment.

The Sunshine Act is definitely in the spotlight these days. Managing all the data certainly presents a challenge, but Michael Krouse, CEO at the Ontario, California, Convention and Visitor’s Bureau offers advice for meeting planners on how to simplify the process of tracking physician spend at medical meetings.

Krouse advises planners to negotiate packages with the venues, look for hotels willing to bundle, and find venues that offer the most value for the physicians. He suggests planners negotiate a flat meal rate for physicians, have internet service bundled into room charges and work with the local convention and visitor’s bureau to find multiple hotels willing to offer lodging at the same rate.

Social media marketing has been lurking in the wings for life sciences companies. A new survey of healthcare professionals finds nearly three quarters of respondents have been conservative in the use of social media. Respondents attribute their careful approach to (spoiler alert)…lack of FDA guidance. Of the existing platforms, YouTube was the clear winner, with 68% of respondents saying it was the most appropriate for sharing information. Twitter and Flickr received the lowest marks.  About half of those surveyed say companies should monitor social media sites to understand patient needs and concerns.

The curtain continues to rise on FCPA investigatory expenses at Wal-Mart. The company nearly doubled its budgeted projections for investigations. During the first quarter, the company spent $73 million on investigation and compliance program expenses. So far, Wal-Mart has spent $230 million on its FCPA investigation.

Our grand finale this week takes us to Australia where the government is under pressure to prohibit facilitation payments. The Organization for Economic Co-operation and Development (OECD) has criticized the country for not taking ant-bribery seriously. Australian companies facing strict anti-bribery laws while operating in other countries may now face books and records violations in their own country, since facilitation payments are usually not recorded. One expert believes Australia will change its law to mirror the UK Bribery Act, and suggests companies adopt a global approach to anti-corruption rather than one focused on managing multiple local requirements.

As the final curtain falls on this week’s production, we close by focusing on your own anti-corruption training requirements. Investigatory costs are high and more countries are making the bribery of government officials a priority. If anti-corruption training is high on your radar, PharmaCertify’s Understanding and Preventing Bribery in the Global Life Sciences Marketplace features a comprehensive review of the FCPA and Anti-kickback Statute, with case studies targeted specifically to the pharmaceutical industry.

With that, we’ll take our final bow and wish everyone a good day and great week!

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